Application 075352

Type: ANDA
Sponsor: DAVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	CAPSULE;ORAL	5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075352-001	SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB		1998-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A075352-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL		1998-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL		1998-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL		1998-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL		1998-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075352-001	SELEGILINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	AB	1998-11-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075352-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075352-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075352-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075352-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075352-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075352-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075352-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075352-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075352-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075352-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075352-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075352-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075352-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075352-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075352-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075352-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075352-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075352-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075352-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075352-001	AB	1	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	A075352-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075352-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075352-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075352-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075352-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075352-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075352-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075352-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075352-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075352-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075352-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075352-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075352-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075352-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075352-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075352-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075352-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	df88d6bf-0fda-3825-e053-2a95a90a3a75	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075352 application number: ANDA075352 ndc (product): 10135-737
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Bryant Ranch Prepack	b8eb0a00-adc7-4aaf-987c-fa1b207b2996	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075352 application number: ANDA075352
Selegiline Hydrochloride	SELEGILINE HYDROCHLORIDE	Novitium Pharma LLC	e42d99b0-c62e-49d4-b792-1301bb539b92	2021-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075352 application number: ANDA075352 ndc (product): 70954-504

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-737	Selegiline Hydrochloride	Selegiline Hydrochloride	Marlex Pharmaceuticals, Inc.	ANDA	Current
60429-019	SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	ANDA	Current
60429-019	SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	ANDA	Current
67253-700	SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	Par Pharmaceutical	ANDA	Current
67253-700	SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	Par Pharmaceutical	ANDA	Current
68151-2649	SELEGILINE HYDROCHLORIDE	SELEGILINE HYDROCHLORIDE	Carilion Materials Management	ANDA	Current
70954-504	Selegiline Hydrochloride	Selegiline Hydrochloride	Novitium Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8629	ORIG	1998-11-30